Investigation of adverse events following bacille Calmette-Guérin immunization using immunization safety surveillance system in Korea Centers for Disease Control and Prevention

Abstract

Purpose The report of adverse events following immunization (AEFI) in Korea has continued since 1994, and the most frequently reported cases of AEFI of Korea Centers for Disease Control and Prevention (KCDC) is bacille Calmette-Guérin (BCG). Meanwhile, various inoculation methods and strains have been used in the past 6 years in Korea. Therefore, we investigated AEFI of BCG by strain types and inoculation methods using immunization safety surveillance of KCDC. Materials and Methods We reviewed BCG AEFIs registered in the KCDC from January 2013 to June 2018. Results There were 336 AEFI cases during the period, and average time interval from vaccination to symptom onset was within 2 months. AEFI proportion was 6.4 cases per 100,000 doses for BCG percutaneous Tokyo strain, 41.6 cases per 100,000 doses of BCG intradermal Danish strain, and 25.9 cases per 100,000 doses of BCG intradermal Tokyo strain. Intradermal type was more reported AEFI than percutaneous type in the same strain. The most common adverse events were local reaction like BCG lymphadenitis and severe adverse reactions such as osteomyelitis or disseminated BCG disease were 0.1 to 0.2 cases per 100,000 doses which are correlated with the range of World Health Organization published AEFI rates. Conclusion The AEFI reporting rate does not equal the actual proportion of AEFI occurrence. Because AEFI monitoring is a passive surveillance system, various factors might influence the number of events reported. Nevertheless, it is important to analyze BCG AEFI by vaccine strains and inoculation method using surveillance data of KCDC.

Epidemiological characteristics and trends of Bacillus Calmette–Guérin lymphadenitis in Shanghai, China from 2010 to 2019

“…During 2010 to 2019, BCG lymphadenitis accounted for 91.06% of AEFIs after BCG vaccination in Shanghai, China, similar to the monitoring results reported by a hospital (91.58%) during 2007 to 2016, 11 but higher than the AEFI monitoring data of China (84.26%) 5 and South Korea (67.05%) 12 and the results of other studies (61.33%–80.43%). 13–15 During the study period, the incidence of BCG lymphadenitis was 173 per 1,000,000 doses, higher than the national level of BCG lymphadenitis (33 per 1,000,000).…”

“…The average cost of transportation for 20 cases was 3,656 RMB (range: 302-9,670 RMB), as shown in Table 3. 11 but higher than the AEFI monitoring data of China (84.26%) 5 and South Korea (67.05%) 12 and the results of other studies (61.33%-80.43%). [13][14][15] During the study period, the incidence of BCG lymphadenitis was 173 per 1,000,000 doses, higher than the national level of BCG lymphadenitis (33 per 1,000,000).…”

“…7 A study by Soh et al found that the sharp increase in BCG lymphadenitis might be related to the vaccine batch number, after excluding vaccine administration–related and host–related factors. 26 After the vaccine strain was switched, more BCG lymphadenitis cases were found in the United States, 9 Saudi Arabia, 27 South Korea, 12 and Gaza. 15 The Denmark II strain has been used in China since 1993.…”

“…The risk of BCG lymphadenitis is higher with subcutaneous BCG vaccination than with intradermal vaccination. 12 The BCG vaccination method used in China is intradermal vaccination which is more stringent. Nurses are prone to inject BCG vaccine into the subcutaneous or intramuscular region when they are not skilled, which leads to an increased risk of BCG lymphadenitis.…”

“…The risk of BCG lymphadenitis is higher with subcutaneous BCG vaccination than with intradermal vaccination. 12 The BCG vaccination method used in China is intradermal vaccination which is more stringent.…”